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3M Attest Super Rapid 5 Steam‑Plus Challenge Pack 41482V

3M Attest Super Rapid 5 steam plus Challenge pack 41482 VProduct DescriptionThe 3M Attest Super Rapid 5 steam plus Challenge pack 41482V is specifically designed for routinely challenging and conducting qualification testing of 270 F (132 C) and 275 F (135 C) dynamic air removal (pre vacuum) steam sterilization processes in healthcare facilities. The Challenge pack consists of multiple layers of medical index cards, some of which are die cut to contain the monitoring products. The stacked cards are wrapped with a sterilization wrap. Each Challenge pack has a process indicator on the pack label that changes from yellow to brown or darker when exposed to steam . This convenient disposable Challenge pack presents a Challenge to the sterilization process equivalent to the user assembled biological indicator (BI) Challenge test pack (towel PCD) recommended by the Association for the Advancement of Medical Instrumentation (AAMI).

3M™ Attest™ Super Rapid 5 Steam‑Plus Challenge Pack 41482V Product Description The 3M™ Attest™ Super Rapid 5 Steam‑Plus Challenge Pack 41482V is specifically designed for routinely challenging and conducting qualification testing of 270°F (132°C) and 275°F

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Transcription of 3M Attest Super Rapid 5 Steam‑Plus Challenge Pack 41482V

1 3M Attest Super Rapid 5 steam plus Challenge pack 41482 VProduct DescriptionThe 3M Attest Super Rapid 5 steam plus Challenge pack 41482V is specifically designed for routinely challenging and conducting qualification testing of 270 F (132 C) and 275 F (135 C) dynamic air removal (pre vacuum) steam sterilization processes in healthcare facilities. The Challenge pack consists of multiple layers of medical index cards, some of which are die cut to contain the monitoring products. The stacked cards are wrapped with a sterilization wrap. Each Challenge pack has a process indicator on the pack label that changes from yellow to brown or darker when exposed to steam . This convenient disposable Challenge pack presents a Challenge to the sterilization process equivalent to the user assembled biological indicator (BI) Challenge test pack (towel PCD) recommended by the Association for the Advancement of Medical Instrumentation (AAMI).

2 The Challenge pack is a single use Challenge pack contains a 3M Attest Super Rapid Readout Biological Indicator 1492V (brown cap, hereinafter referred to as a 1492V BI), a 3M Comply SteriGage steam Chemical Integrator, and a record keeping sheet. AAMI recommends that steam sterilization loads containing an implant be monitored with a process Challenge device containing a biological indicator and an integrating indicator. Comply SteriGage steam Chemical Integrators are Type 5 (Category i5) Integrating Indicators as categorized by ISO 11140 1:2014. Comply SteriGage steam Chemical Integrators are single use chemical indicators consisting of a paper wick and a steam and temperature sensitive chemical pellet contained in a paper/film/foil laminate. The chemical pellet melts and migrates as a dark color along the paper wick.

3 The migration is visible through a window marked ACCEPT or REJECT; the extent of migration depends on steam , time, and temperature. The Comply SteriGage steam Chemical Integrator offers an immediate Accept/Reject reading that allows for implant load early release in emergency situations as defined in AAMI ST 1492V BI is a self contained dual readout biological indicator specifically designed for Rapid and reliable monitoring of the steam sterilization process when used in conjunction with the 3M Attest Auto reader 490, hereinafter referred to as the 490 Auto reader. When steam processed, the process indicator on the top of the 1492V BI cap changes color from pink to light brown or darker. 3M Attest 1492V biological indicator controls are provided with the Challenge 1492V BI utilizes the glucosidase enzyme system, which is generated naturally within growing cells of Geobacillus stearothermophilus.

4 The glucosidase in its active state is detected by measuring the fluorescence produced by the enzymatic hydrolysis of a non fluorescent substrate, 4 methylumbelliferyl D glucoside (MUG). The resultant fluorescent by product, 4 methylumbelliferone (MU), is detected in the 490 Auto reader. The presence of fluorescence within 1 hour of incubation of the 1492V BI in the 490 Auto reader indicates a steam sterilization process 1492V BI can also indicate the presence of G. stearothermophilus organisms by a visual pH color change reaction. Biochemical activity of the G. stearothermophilus organism produces metabolic by products that cause the media to change color from purple to yellow which also indicates a steam sterilization process failure. Use of this indication method is optional and is typically restricted to special TimesThe 1 hour Super Rapid readout and the optional 48 hour visual pH color change incubation times have been correlated with a 7 day incubation period (at 56+/ 2 C) following the FDA s Reduced Incubation Time protocol.

5 Processed indicators were examined at 48 hours and 7 days for detection of a visual pH color change. The 1 hour fluorescence change readings and the 48 hour visual pH color change readings were compared to the 7 day visual pH color change readings to determine the readout time of the hour Fluorescence Change Result1492V BIs have 1 hour reduced incubation time results that correlate to the 7 day (168 hours) visual readout result 97% of the hour Visual pH Color Change Result1492V BIs have 48 hour reduced incubation time results that correlate to the 7 day (168 hours) visual readout result 97% of the to the high reliability of the 1 hour fluorescent result, there is no advantage to incubating 1492V BIs beyond 1 BIs meet ANSI/AAMI/ISO 11138 1:2006/(R)2010, ANSI/AAMI/ISO 11138 3:2006/(R)2010 and EN/ISO 11138 1.

6 2006, EN/ISO 11138 3 for UseUnited StatesUse the 3M Attest Super Rapid 5 steam plus Challenge pack 41482V in conjunction with the 3M Attest Auto reader 490 to qualify or monitor dynamic air removal (pre vacuum) steam sterilization cycles of 4 minutes at 270 F (132 C) and 3 minutes at 275 F (135 C). The 3M Attest Super Rapid Readout Biological Indicator 1492V contained in the Challenge pack provides a final fluorescent result in 1 hour. An optional visual pH color change result is observed in 48 the United StatesUse the 3M Attest Super Rapid 5 steam plus Challenge pack 41482V in conjunction with the 3M Attest Auto reader 490 to qualify or monitor 270 F (132 C) to 275 F (135 C) dynamic air removal (pre vacuum) steam sterilization is a glass ampoule inside the plastic vial of the biological indicator.

7 To avoid the risk of serious injury or death from flying debris due to a ruptured ampoule: Allow the biological indicator to cool for the recommended time period before activating. Activating or excessive handling of the BI before cooling may cause the glass ampoule to burst. Wear safety glasses when activating the biological indicator. Handle the biological indicator by the cap when crushing and flicking. Do not use your fingers to crush the glass To ensure the Challenge pack delivers the intended Challenge : DO NOT OPEN Challenge pack prior to sterilization; DO NOT reuse Challenge DO NOT use the Challenge pack to monitor sterilization cycles which it is not designed to Challenge :a. Gravity displacement steam sterilization cycles;b. 250 F (121 C) dynamic air removal (pre vacuum) steam sterilization cycles;c.

8 270 F (132 C) dynamic air removal (pre vacuum) steam sterilization cycles having exposure times <4 minutes or 275 F (135 C) dynamic air removal (pre vacuum) steam sterilization cycles having exposure times <3 minutes;d. Dry heat, chemical vapor, ethylene oxide or other low temperature sterilization After 1492V BI activation, ensure media has flowed to the spore growth FrequencyFollow facility Policies and Procedures which should specify a biological indicator monitoring frequency compliant with professional association recommended practices and/or national guidelines and standards. As a best practice and to provide optimal patient safety, 3M recommends that every steam sterilization load be monitored with a biological indicator in an appropriate Process Challenge Device ( , BI Challenge test pack ).

9 Directions for Use1. Place an Attest Super Rapid 5 steam plus Challenge pack 41482V flat, with the label side up, in a full load in the most challenging area for the sterilant to reach. This is generally on the bottom shelf, over the drain. Do not place objects ( another pack ) on top of the Challenge pack . This will create too great of a Challenge for air removal and steam Process the load according to established After completion of the cycle, while wearing heat resistant gloves, retrieve the Challenge pack . 4. Check to see that the external process indicator on the outside of the Challenge pack has changed from yellow to brown or darker. Open the Challenge pack and allow the 1492V BI to cool outside the Challenge pack for 10 minutes prior to Check the Comply SteriGage steam Chemical Integrator.

10 The dark color should have entered the ACCEPT window. If the dark color has not entered the ACCEPT window, this indicates a REJECT result which means the load was not exposed to sufficient steam sterilization conditions. This load should not be released for use but reprocessed. Record integrator Check the process indicator on the top of the 1492V BI cap. A color change from pink to light brown or darker confirms that the biological indicator has been exposed to the steam process. This color change does not indicate that the steam process was sufficient to achieve sterility. If the process indicator is unchanged, check the sterilizer physical Identify the processed 1492V BI by writing the sterilizer, load number, and processing date on the indicator label. Do not place another label or indicator tape on the biological For a permanent record, fill out the required information on the record keeping card.


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